Study of an Approved Drug in Patients With Asthma - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092144

Purpose

The purpose of this study is to assess the efficacy and safety of an approved drug on asthma symptoms in patients with chronic asthma which is also active during the allergy season.

Condition	Intervention	Phase
Asthma	Drug: MK0476, montelukast sodium / Duration of Treatment: 4 weeks Drug: Comparator: placebo / Duration of Treatment: 4 weeks	Phase III

MedlinePlus related topics: Allergy Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral MK0476 Vs Placebo During the Allergy Season in Patients With Seasonal Aeroallergen Sensitivity and Chronic Asthma Which is Also Active During Allergy Season

Further study details as provided by Merck:

Primary Outcome Measures:

To assess daytime asthma symptoms as measured by daily diaries over a 3-week treatment period

Secondary Outcome Measures:

To assess the following over a 3-week treatment period:
nighttime symptoms
AM PEFR
PM PEFR
B-agonist use
asthma attacks
discontinuations due to asthma

Estimated Enrollment:	500
Study Start Date:	March 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Asthma symptoms brought on by allergies

Exclusion Criteria:

Patient has any lung disease
Currently have a sinus infection or cold symptoms

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

Busse WW, Casale TB, Dykewicz MS, Meltzer EO, Bird SR, Hustad CM, Grant E, Zeldin RK, Edelman JM. Efficacy of montelukast during the allergy season in patients with chronic asthma and seasonal aeroallergen sensitivity. Ann Allergy Asthma Immunol. 2006 Jan;96(1):60-8.

Study ID Numbers:	2004_028
Study First Received:	September 21, 2004
Last Updated:	July 5, 2006
ClinicalTrials.gov Identifier:	NCT00092144
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Montelukast
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Leukotriene Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses
Hormone Antagonists

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009